January 28, 2022
At the outset of the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) quickly moved to waive a number of regulatory requirements. These waivers provided hospitals and health systems with critical flexibilities to manage what has been a prolonged and unpredictable pandemic.
Hospitals and health systems used these newly permitted tools to increase capacity, separate areas of care for COVID-19 and non-COVID-19 patients, expand testing and telehealth capabilities, and mitigate workforce challenges. While these flexibilities were created as a direct response to the COVID-19 public health emergency (PHE), our members have found that this process acted as a catalyst for establishing new, innovative and safe ways for delivering patient-centered care.
Recognizing the potential long-term benefit of many of these waivers, we urge CMS to consider taking action under its own authority or in conjunction with Congress, where necessary, to make certain flexibilities permanent while providing a post-PHE transition period for several other flexibilities.
In addition to taking action to extend some waivers while making others permanent, we urge CMS to consider employing significant enforcement discretion for some time after the PHE is terminated. The pandemic initially forced, and continues to require, our members to take unprecedented steps to manage surges in COVID-19 cases, limit infection and spread of a highly transmissible virus, mitigate workforce shortages, navigate limited availability of critical supplies, and rapidly respond to changes in patient needs and clinical protocols for both acute and post-acute care. Once the PHE ends, it will undoubtedly take time for hospitals, health systems and post-acute care providers to transition out of this mode of operation and determine appropriate transitions of care for patients, especially those with long COVID. In recognition of these challenges, the use of enforcement discretion by the agency will be vital to ensuring a smooth shift to a post-PHE health care delivery world.
The following are waivers we would like to see extended or made permanent, and what actions are required to make that happen:
- Permanently eliminate the telehealth originating and geographic site restrictions for all telehealth services (requires legislation).
- Permanently allow rural health clinics and federally qualified health centers to continue to serve as distant sites for all telehealth services beyond mental health services (requires legislation).
- Permanently expand eligibility to deliver telehealth services to certain practitioners, such as respiratory therapists, physical therapists, occupational therapists and speech language therapists (requires legislation).
- Permanently allow providers to deliver all Medicare telehealth services (beyond mental health services) via audio only communications when medically appropriate (can be achieved through regulation).
- Permanently allow professionals who provide hospice and home health services to do so via telehealth and grant these professionals the ability to meet face-to-face requirements via virtual visits, including audio-only visits (requires legislation).
- Permanently allow direct supervision through telecommunications technology for specified services (can be achieved through regulation).
- Permanently allow hospital outpatient departments (HOPDs) and critical access hospitals to bill for telehealth services; or, alternatively, clarify the Health and Human Services Secretary’s authority to enable hospitals to bill for outpatient psychiatry programs and other outpatient therapy services delivered through remote connection in order to provide increased access to those individuals in need of these services (requires legislation).
- Permanently allow hospitals to bill the originating site fee when hospital-based clinicians provide telehealth services to patients at home who would normally receive services at an HOPD (requires legislation).
- Ensure remote patient monitoring is treated similarly to other existing telehealth flexibilities in terms of coverage (can be achieved through regulation).
- Permanently eliminate the currently separate consent process for telehealth services and use the telehealth encounter as presumed consent (can be achieved through regulation).
- Permanently grant an exception for practitioners in states that have medical licensing reciprocity requirements to file separate Drug Enforcement Agency registration in any state a provider practices to ensure appropriate prescribing for patients through telehealth services (requires legislation).
- Temporarily continue to waive the restrictions on the type of technology that may be used to provide telehealth by allowing the use of everyday communications technologies, such as FaceTime or Skype (can be achieved through regulatory enforcement discretion.
Hospital at Home
- To allow for hospitals and health systems to increase capacity and keep patients as safe as possible, CMS took action to expand accessibility to hospital at home programs. CMS waived section 482.23(b) and (b)(1) of the Conditions of Participation (CoPs), which require nursing services to be provided on premises 24 hours a day, seven days a week, and the immediate availability of a registered nurse for care of any patient. The program has proven to be successful, and a continuation of this waiver likely will be necessary while additional legislative and regulatory action around making permanent the hospital at home-related waiver is considered. (Requires legislation.)
- Permanently eliminate specific practice limitations on nurse practitioners that are more restrictive under CMS rules than under state licensure (can be achieved through regulation).
- Permanently remove certain licensure requirements to remove barriers for states wishing to allow out-of-state providers to perform telehealth services (requires legislation).
- Allow extensions to residency cap-building periods for new graduate medical education programs to account for COVID-19-related challenges, such as recruitment, resource availability and program operations (can be achieved through regulation).
Quality, Patient Safety and Privacy
- Make permanent appropriate changes to the CoPs, such as reconsidering use of verbal orders and certain requirements associated with discharge planning to better equip providers to assist patients (can be achieved through regulation).
- Permanently scale back current regulations and reconsider the importance of the specific information that is most useful to patients when being discharged to post-acute care facilities, including nursing homes (can be achieved through regulation).
- Permanently continue measure suppression policy that allows CMS to exclude quality data adversely affected by the COVID-19 pandemic and other extenuating circumstances in calculating performance in CMS quality reporting and value programs (can be achieved through regulation).
- Continue to grant relief on timeframes related to pre- and post-admission patient assessment and evaluation criteria to ensure patients are treated in a timely manner and allow hospitals to better manage an influx of non- COVID-19 patients returning for care (can be achieved through regulation).
- Continue to allow pathologists and other laboratory personnel to perform certain diagnostic tests and review remotely through a secure network to ensure continued patient access to the best possible care (can be achieved through regulation).
- Continue to maintain flexibility in supervision requirements of diagnostic services by continuing to allow the virtual presence of a physician through audio or video real-time communications technology when the use of the technology is indicated to reduce exposure risk for the beneficiary or provider (can be achieved through regulation).
- Coordinate with stakeholders to establish a program to account for unavoidable quality data gaps in order to hold hospitals harmless (requires legislation).
- Temporarily limit or waive payment adjustments in program years where CMS determines that, as a result of measure reporting exceptions and suppressions, it has insufficient data to calculate national performance in a reliable manner (can be achieved through regulation).
- Temporarily continue the waiver of sanctions and penalties against hospitals that do not comply with elements of the HIPAA privacy rule (can be achieved through regulatory enforcement discretion).
Care Delivery in Rural Areas
- Permanently increase flexibility for site-neutral payment exceptions for providers seeking to relocate HOPDs and other off-campus provider-based departments in order to better and more effectively serve their communities (can be achieved through regulation).
- Continue to support increased bed capacity in rural areas when an emergency requires such action, holding hospitals harmless for increasing bed capacity during an emergency in the future while allowing those providers to maintain pre-emergency bed counts for applicable payment programs, designations and other operations (can be achieved through regulation).
Waivers Previously Requested by AHA that Have Not Yet Been Granted
- 340B Hospital Eligibility and COVID-19-Related Payer Mix Changes. Provide flexibility through the 1135 waiver process to ensure that 340B hospitals that were participating in the 340B program at any point during the COVID-19 PHE and may have experienced changes to their Medicare disproportionate share hospital (DSH) adjustment percentage in fiscal year (FY) 2020 or FY 2021 due to the COVID-19 pandemic retain their 340B eligibility. For many 340B hospitals, eligibility is tied to their Medicare DSH adjustment percentage. Hospitals should not be penalized by losing their 340B eligibility due to temporary payer mix changes that were a direct result of the COVID-19 pandemic. Programs like 340B that provide critical resources to hospitals that should be safeguarded while hospitals continue to be on the front lines of the pandemic. (Can be achieved through regulatory waiver authority or legislation).
- Increasing Inpatient Capacity through Prior Authorization Waivers. In order to increase inpatient capacity to meet the demands of the PHE, hospitals look to expeditiously move patients who are ready for discharge to the next setting of care. However, health plan prior authorization policies frequently delay the movement of such patients by days if not weeks. We request that CMS direct all Medicare Advantage plans to waive prior authorization for post-acute sites of care during the PHE and, where in-network capacity may be limited, allow for placement of such individuals in out-of-network sites of care (requires legislation).